US11559387B2 - Substrate with rotatable struts for medical device - Google Patents

Abstract

A medical device comprises a substrate (10) defining a major surface (9) defining a plane, including a plurality of first struts (14) along a first direction interconnected with a plurality of second struts (12) extending along a second direction not parallel with the first direction, wherein widths (11) of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections (15) of the second struts (12) rotate relative to the first struts (14) and the intermediate sections of the second struts bend out of the plane of the major surface. The medical device is operable to extend and/or retract elements suitable for a particular purpose. The elements are extended and/or retracted in response to a stress applied by way of stretching and/or retracting the device, among other methods. The elements may remain extended and/or retracted or may recoil back to an initial position upon the removal of the force. In various embodiments, the elements are used to treat or deliver treatment to a target site within a body.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application is a national phase application of PCT Application No. PCT/US2018/049983, internationally filed on Sep. 7, 2018, which claims the benefit of Provisional Application No. 62/557,488, filed Sep. 12, 2017, both of which are herein incorporated by reference in their entireties for all purposes.

FIELD

The present disclosure relates generally to medical devices.

SUMMARY

Various aspects of the present disclosure are directed toward a medical device including a substrate defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction that are interconnected with a plurality of second struts extending along a second direction not parallel with the first direction along the major surface. Widths of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend out of the plane of the major surface prior to the stretching.

In some embodiments, the medical device further comprises a plurality of projections extending from intermediate sections of the plurality of second struts. When the substrate is stretched along the second direction, the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative to the plurality of first struts.

The plurality of projections may optionally include anchors. In a variety of embodiments, such anchors may be operable to perform one or more of: anchor into tissue, deliver drugs to tissue, stimulate tissue, conceal tissue, expose tissue, secure tissues together, and secure tissue to a medical device, such as a graft or other component of an implantable medical device. In the same or different embodiments, such projections may represent the projections that includes microneedles operable to deliver a therapeutic fluid or collect a sample.

Various aspects of the present disclosure are also directed toward a medical system including a medical device of the preceding paragraphs, and a delivery device configured to induce the stretching of the substrate. A deployment of the medical device includes stretching of the substrate such that the second struts rotate relative to the first struts.

Various aspects of the present disclosure are also directed toward a medical system including a medical device of the preceding paragraphs, and a delivery device configured to deliver the medical device within a confined orifice of a patient. The substrate is a flat sheet curled up within the delivery device. The delivery device is operable to deploy the substrate within the confined orifice such that the flat sheet at least partially uncurls within the confined orifice. The medical device is configured to be used as a hernia patch with the plurality of projections being configured to contact or penetrate a tissue of the patient adjacent an opening in the tissue at a herniation.

Various aspects of the present disclosure are also directed toward a medical system including a medical device of the preceding paragraphs, and a delivery device configured to deliver the medical device within a vasculature of a patient with the medical device in a collapsed configuration. The delivery device is operable to deploy the tubular substrate within the vasculature. A deployment of the medical device includes stretching of the tubular substrate to an expanded configuration such that the second struts rotate relative to the first struts.

Various aspects of the present disclosure are also directed toward methods of manufacturing a medical device of the preceding paragraphs, the method comprising cutting a sheet of substrate material to form the substrate including the plurality of first struts and the plurality of second struts. The plurality of first struts are interconnected with the plurality of second struts in the cut sheet of substrate material.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.

FIG.1 illustrates an example substrate defining longitudinal and lateral struts in a major surface with barbed projections extending from intermediate sections of the lateral struts, in accordance with an embodiment.

FIGS.2A-2D illustrate rotation of the barbed projections of the example substrate ofFIG.1 after stretching the substrate along a longitudinal direction from an initial state.

FIGS.3A and3B illustrate an example substrate defining longitudinal and lateral struts in a major surface with barbed projections extending from intermediate sections of the lateral struts, in accordance with an embodiment.

FIGS.4A-4K illustrate example projection configurations suitable for use with a substrate providing rotatable struts with projections, in accordance with various embodiments.

FIGS.5A and5B illustrate an example substrate defining serpentine longitudinal struts and lateral struts in a major surface with projections extending from rotatable intermediate sections of the lateral struts, in accordance with an embodiment.

FIG.6 illustrates an example substrate defining longitudinal and lateral struts in a major surface with microneedle projections extending from rotatable intermediate sections of the lateral struts, the struts including lumens in fluid communication with the microneedle projections, in accordance with an embodiment.

FIGS.7A and7B illustrate a balloon inflatable vascular drug delivery system including a substrate defining circumferential and lateral struts in a tubular major surface with projections extending from rotatable intermediate sections of the lateral struts, in accordance with an embodiment.

FIGS.8A-8D illustrate deployment of barbed sleeves from projections operable to secure two tissue layers together, in accordance with an embodiment.

FIGS.9A-9D illustrate a medical device suitable for endoluminal delivery, the medical device including a diametrically adjustable tubular substrate with rotatable struts mounted on an elongated member, in accordance with an embodiment.

FIGS.10A-10C illustrate removing a thrombus from a vasculature of a patient using the medical device ofFIGS.9A-9D, in accordance with an embodiment.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

Embodiments presented herein include a medical device operable to extend and/or retract elements suitable for a particular purpose. The elements are extended and/or retracted in response to a stress applied by way of stretching and/or retracting the device, among other methods. The elements may remain extended and/or retracted or may recoil back to an initial position upon the removal of the force. In various embodiments, the elements are used to treat or deliver treatment to a target site within a body. In the same or different embodiments, the elements may provide fixation for the medical device.

FIG.1 illustrates anexample substrate10 defining amajor surface9 including a plurality oflateral struts12 and a plurality oflongitudinal struts14.Lateral struts12 extend along a first direction and are interconnected withlongitudinal struts14, which extend along a second direction not parallel with the first direction along themajor surface9. In some but not all embodiments, the first direction may be about perpendicular to the second direction. Thesubstrate10 is configured such that when thesubstrate10 is stretched along a longitudinal direction, a direction perpendicular to the first direction, thelateral struts12 rotate relative to thelongitudinal struts14 and bend out of a plane defined by themajor surface9 prior to the stretching. As referred to herein stretching along a direction means at least a part of the stretching is within the dimension of the direction, that is, the stretching, as a whole, need not be perpendicular to the direction.

The rotation of thelateral struts12 occurs in response to stretching along the longitudinal direction as a result of the widths11 oflateral struts12 as measured along themajor surface9 being larger than thicknesses (not shown inFIG.1) oflateral struts12 measured perpendicular to themajor surface9. The widths only need to be marginally larger than the thicknesses as rotation occurs once the bending resistance across the thickness is less than bending resistance across the width of a strut; however, the designed width and thickness should account for any manufacturing tolerances to have reliable rotation for all of the lateral struts in response to the stretching of thesubstrate10. At least theintermediate sections15 of thelateral struts12 are configured to rotate relative to thelongitudinal struts14 and bend out of the plane of themajor surface9, the plane being defined prior to the stretching, whensubstrate10 is exposed to a stretching force. In conjunction with or following the rotation of theintermediate sections15 of thelateral struts12, theintermediate sections15 of thelateral struts12 bend in a plane parallel to the widths of thelateral struts12 in conjunction with elongation of thesubstrate10, for example, as shown inFIGS.2C and2D. The plane parallel to the widths of thelateral struts12 includesmajor surface9 at thelateral struts12 and is generally parallel to the plane defined bydirections30,32 for aplanar substrate10.

In some examples, all or substantially all of thelateral struts12 are configured to rotate relative to thelongitudinal struts14 and bend out of the plane of themajor surface9 when exposed to a stretching force. In such examples, such as theexample substrate40 ofFIGS.3A-3B,longitudinal struts14 or thestrut interconnections13 betweenlongitudinal struts14 and lateral struts12 bend to allow the rotation of substantially all potions of lateral struts12. In other examples, lateral struts12 may twist to facilitate rotation of theintermediate sections15 of the lateral struts. In such examples, thestrut interconnections13 may be reinforced to resist bending oflongitudinal struts14 or thestrut interconnections13 betweenlongitudinal struts14 and lateral struts12. Such reinforcement may include a widening of longitudinal struts14 (e.g., in the plane ofdirections30,32) relative tolateral struts12 as compared to the examples ofFIGS.1-3B.

In the example ofFIG.1,barbed projections16 extend fromintermediate sections15 of the lateral struts12. When thesubstrate10 is stretched along a longitudinal direction, thebarbed projections16 rotate with the lateral struts12 relative to thelongitudinal struts14 to project outwardly relative to thelongitudinal struts14, as shown inFIGS.2A-2D. The magnitude of rotation is controllable by the magnitude of stretching along the longitudinal direction.

In addition, the rotation of theprojections16 may be augmented by providing the lateral struts12 with a predetermined geometry, as with the example of thesubstrate10. Specifically, each of the lateral struts12 define a geometry that alternately extends at an angle to a transverse direction defining a serpentine portion with peaks and valleys withlongitudinal struts14 interconnecting lateral struts12 adjacent apexes of the peaks and valleys.Projection interconnections17 between lateral struts12 andprojections16 are between the apexes of the peaks and valleys. Such a configuration can increase the degree of rotation of theprojections16 when thesubstrate10 is stretched along a longitudinal direction as compared to embodiments in which the lateral struts12 do not incorporate peaks and valleys. In the specific embodiment ofFIG.1, the serpentine portion of lateral struts12 includes V-shaped portions including the peaks and valleys. In other embodiments, the serpentine portion of lateral struts12 may include U-shaped portions including the peaks and valleys, or other configurations.

In the embodiment ofFIG.1,barbed projections16 extend along themajor surface9 in a direction that is about parallel tolongitudinal struts14. Thesubstrate10, including themajor surface9, may be about flat. As such, thesubstrate10 defining the lateral struts12,longitudinal struts14, and optionally all or a portion ofbarbed projections16 may be cut from a flat sheet. In an alternative embodiment, thesubstrate10, including themajor surface9, may be tubular such that lateral struts12,longitudinal struts14, and optionally all or a portion ofbarbed projections16 may be cut from a tube. In either embodiment, relatively simple manufacturing techniques may be utilized to make the medical device that is operable to provide rotatable lateral struts12 withprojections16, which are configured to rotate relative to thelongitudinal struts14 and relative to the originalmajor surface9 in response to longitudinal stretching of the substrate material.

With respect to embodiments including asubstrate10 cut from a tube, referred herein as a tubular substrate10a, the pattern of cuts to form lateral struts12,longitudinal struts14 optionally all or a portion ofbarbed projections16 may be oriented in any direction about the major surface, such that radial stretching, for example, as shownFIGS.7A and7B, stretching along a length of the tubular substrate10a, or a combination thereof may result in the rotation ofbarbed projections16.

The tubular substrate10adefining lateral struts12 andlongitudinal struts14 defines a tubular major surface defining a longitudinal axis. In such embodiments,projections16 may extend about parallel to the longitudinal axis when the tubular substrate10ais in the unstretched condition, and theprojections16 may extend radially outward when the tubular substrate10ais stretched in the longitudinal direction parallel with the longitudinal axis. Some or all ofprojections16 may also be oriented to extend inward when the tubular substrate10ais stretched in the longitudinal direction.

Example steps for manufacturing a medical device including thesubstrate10 may include cutting a sheet of substrate material to form thesubstrate10 including thelongitudinal struts14 and lateral struts12 withstrut interconnections13, as well asbarbed projections16 or base portions ofbarbed projections16, i.e., the portions connected tointermediate sections15. As discussed above,longitudinal struts14 may be interconnected withlateral struts12 in the cut sheet of substrate material according to the pattern of the cutting to providestrut interconnections13. In addition, also according to the pattern of the cutting,barbed projections16 extend from theintermediate sections15 of lateral struts12 in the cut sheet of substrate material. In various embodiments, the sheet of substrate material may be a tubular sheet of substrate material or a flat sheet of substrate material. In a tubular sheet of substrate material, lateral struts12 and/orlongitudinal struts14 may form tubular or generally helical rings according to the pattern of the cutting.

The method may further include stretching thesubstrate10 along a direction perpendicular to the longitudinal direction, i.e., in a direction nonparallel to the longitudinal direction, to rotate the lateral struts12 relative to thelongitudinal struts14 and rotate theprojections16 relative to thelongitudinal struts14. In conjunction with or following the rotation of theintermediate sections15 of the lateral struts12, theintermediate sections15 of the lateral struts12 bend in a plane parallel to the widths of the lateral struts12 in conjunction with elongation of thesubstrate10, for example, as shown inFIGS.2C and2D. Such stretching may be reversible in that it results in elastic deformation of thesubstrate10, or nonreversible in that it results in plastic deformation of thesubstrate10.

The material of thesubstrate10 may include one or more of metal, such as stainless steel, plastic, superelastic metal, such as nitinol, and/or shape memory materials, such as nitinol. In embodiments in which thesubstrate10 includes nitinol, or another elastic material,substrate10 may be configured to self-expand to elongate thesubstrate10 and rotate the lateral struts12 relative to themajor surface9 of thelongitudinal struts14, for example, such thatprojections16 are biased to protrude relative to thelongitudinal struts14. As another example, anelastic substrate10 may be configured to self-contract to retract thesubstrate10, for example, such thatprojections16 are biased to lay flat relative to themajor surface9 of thelongitudinal struts14. Such stretching may be at least predominantly due to mechanical energy rather than thermal energy, although in some examples the nitinol substrate may be temperature-activated.

Barbed projections16 represent anchors including pointed tips with barbs suitable to impede retraction ofprojections16 once deployed within a tissue.Barbed projections16 and other such anchors are operable to penetrate at least one of tissue of a patient and graft material of an implantable medical device, such a graft material of a heart valve device as part of a valve-in-a-valve implantation procedure. In some embodiments,projections16 may be deployable by stretching of thesubstrate10, and retractable by either compressing thesubstrate10, or by removing a stretching force from thesubstrate10.

In different configurations, theprojections16 configured as anchors are operable to perform one of more of: anchor into tissue, deliver drugs to tissue (for example, as discussed in further detail with respect toFIGS.7A and7B), stimulate tissue when coupled to a stimulation generator of a medical device, conceal tissue, expose tissue, secure tissues together, and secure tissue to a medical device, such as a graft or other component of an implantable medical device.

FIGS.2A-2D illustrate rotation of thebarbed projections16 of thesubstrate10 by stretching thesubstrate10 along alongitudinal direction30, such as in a non-perpendicular direction relative tolongitudinal direction30.FIG.2A is a top view illustration of thesubstrate10 in a flat pattern includinglongitudinal struts14, lateral struts12 andbarbed projections16 as cut in a flat sheet of substrate material.Longitudinal direction30 and lateral (width)direction32 are indicated and represent themajor surface9 including thelongitudinal struts14, the lateral struts12, and theprojections16.

FIG.2B is a top view illustration of the application of aforce20 alonglongitudinal direction30 to stretch thesubstrate10 alonglongitudinal direction30.FIG.2C illustrates additional application offorce20 to stretch thesubstrate10 further alonglongitudinal direction30.FIG.2D is a side view illustration of thesubstrate10 stretched alonglongitudinal direction30 as shown inFIG.2C. As shown inFIG.2D,rotation22 of the lateral struts12 and theprojections16 has occurred relative to thelongitudinal struts14 from the stretching of thesubstrate10 along thelongitudinal direction30 such thatprojections16 point in direction24, which is outwardly relative to the unstretched plane of thesubstrate10, including the lateral struts12, and theprojections16. Such rotation occurs because widths11 of lateral struts12 as measured along themajor surface9 are larger than thicknesses of lateral struts12 measured perpendicular to themajor surface9 alongdirection34 such that lateral struts12 are biased to bend within thethickness direction34 rather than thewidth direction32. Theintermediate sections15 of the lateral struts12 bend in a plane parallel to the widths of the lateral struts12 in conjunction with elongation of thesubstrate10 alonglongitudinal direction30.

The rotation is augmented by the geometry of lateral struts12, in that each of lateral struts12 is nonlinear along themajor surface9 such thatintermediate sections15 of lateral struts12 are offset from thestrut interconnections13 between lateral struts12 andlongitudinal struts14 to accentuate the rotation of theprojections16 from the stretching of thesubstrate10 alonglongitudinal direction30.

When thesubstrate10 is stretched alonglongitudinal direction30,intermediate sections15 of lateral struts12 rotate relative tolongitudinal struts14 and bend out of the plane of themajor surface9. In some example, only a portion of lateral struts12 rotate relative tolongitudinal struts14 with other portions of lateral struts12 twisting to allow the rotation. In other examples,longitudinal struts14 may bend to allow most or all portions of lateral struts12 to rotate relative tolongitudinal struts14. In conjunction with or following the rotation of theintermediate sections15 of the lateral struts12, theintermediate sections15 of the lateral struts12 bend in a plane parallel to the widths of the lateral struts12 in conjunction with elongation of thesubstrate10 alonglongitudinal direction30, for example, as shown inFIGS.2C and2D. The magnitude of rotation is controllable by the magnitude of stretching along the longitudinal direction.

Thesubstrate10 as shown represent an example of various features of a substrate and, although the combination of those illustrated features is clearly within the scope of invention, that example and its illustration is not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown inFIGS.1 and2A-2D. For example, in various embodiments, the major surface of thesubstrate10 may instead be a tubular major surface rather than the planarmajor surface9.

EMBODIMENTSEmbodiment 1

FIGS.3A and3B illustrate an examplestainless steel substrate40 defininglongitudinal struts44 and lateral struts42 in amajor surface39 withbarbed projections46 extending fromintermediate sections45 of the lateral struts42. In some embodiments,substrate40 may be a stainless steel substrate.Substrate40 is shown as stretched along a longitudinal direction. In an unstretched configuration (not shown), thewidths41 of lateral struts42 as measured along themajor surface39 are larger than thethicknesses43 of lateral struts42 as measured perpendicular to themajor surface39.

In the embodiment ofFIGS.3A and3B, substantially all portions of the lateral struts42, including theintermediate sections45 of the lateral struts42, are configured to rotate relative to thelongitudinal struts44 and bend out of the plane of themajor surface39 whensubstrate40 is exposed to a stretching force. In conjunction with or following the rotation of theintermediate sections45 of the lateral struts42, theintermediate sections45 of the lateral struts42 bend in a plane parallel to the widths of the lateral struts42 in conjunction with elongation of thesubstrate40. The plane parallel to the widths of the lateral struts42 includesmajor surface39 at the lateral struts42.

Substrate40 is substantially similar to thesubstrate10 except that it is configured to facilitate near perpendicular orientation ofprojections46 relative to themajor surface39 oflongitudinal struts44 when stretched.Barbed projections46 and other such anchors are operable to penetrate tissue of a patient. As withbarbed projections16,barbed projections46 represent anchors suitable to impede retraction, and potentially prevent pullout ofprojections46 once deployed within a patient tissue. In some embodiments,projections16,46 may be deployable by stretching ofsubstrate40, and retractable by either compressingsubstrate40, or by removing a stretching force fromsubstrate40. The magnitude of rotation is controllable by the magnitude of stretching along the longitudinal direction.

As shown inFIG.3B,projections46 each include abase portion47, atip end portion48 distal to the base portion, and abody portion49 between the base portion and the tip end portion. At least thebase portion47 is integral with thetransverse strut42. Although, one or both oftip end portion48 andbody portion49 may also be integral with thetransverse strut42.

Substrates10,40 are suitable for use in a medical device in a variety of configurations for any number of applications. In some embodiments,projections46 may include a removable distal section, such as a coating, a cap or a distal tip. In different embodiments, the removable distal section may include one or more of: an erodible portion, an absorbable portion, a break-off distal portion, a tacky distal portion, a barbed, break-off distal tip, a cap or a barbed sleeve (as shown inFIGS.8A-8C), biological moieties, or other removable distal section. In any of these embodiments, the removable distal section may include a therapeutic compound.

In various embodiments, the form of atip end portion48 may be pointed, configured as an arrowhead, a single-sided arrowhead, barbed, textured, rectangular, square, oval, circular, diamond, triangular, elliptical, polygonal, U-shaped, star-shaped, or in any other configuration suitable for the selected application. A variety of different projection configurations suitable for use with tubular orflat substrates10,40 are illustrated inFIGS.4A-4K.

The projections ofFIG.4A provide triangular profiles.

The projections ofFIG.4B provide pointed tips with serrated edges.

The projections ofFIG.4C provide symmetric barbed tips, i.e., arrowhead.

The projections ofFIG.4D provide asymmetric barbed tips, i.e., single sided arrowhead.

The projections ofFIG.4E provide triangular profiles in an asymmetric arrangement relative to the longitudinal struts.

The projections ofFIG.4F provide pointed tips.

The projections ofFIG.4G provide pointed tips with a series of barbs between the pointed tips and the lateral struts.

The projections ofFIG.4H include coincident projections that extend on both sides of the lateral struts such that the projections are configured to rotate relative to the longitudinal struts and point out of opposing sides relative to the longitudinal struts when the substrate is stretched.

The projections ofFIG.4I include projections that extend on opposing sides of alternating lateral struts such that the projections are configured to rotate relative to the longitudinal struts and point out of opposing sides relative to the longitudinal struts when the substrate is stretched.

The projections ofFIG.4J include apertures which facilitate connecting or threading something through the projections.

The projections ofFIG.4K include rotating paddles which facilitate revealing and obscuring something by the rotation of the paddles.

Embodiment 2

FIGS.5A and5B illustrate anexample substrate100 defining amajor surface99 including serpentinelongitudinal struts114 andlateral struts112 withprojections116 extending from rotatableintermediate sections115 of the lateral struts112. With the exception of serpentinelongitudinal struts114, thesubstrate100 is otherwise similar tosubstrates10,40 and the serpentinelongitudinal struts114 may be combined with elements and features previously described with respect tosubstrates10,40 by replacing withlongitudinal struts14 orlongitudinal struts44 with serpentinelongitudinal struts114.FIG.5A illustrates serpentinelongitudinal struts114 in an extended configuration, whereasFIG.5B illustrates serpentinelongitudinal struts114 in a collapsed configuration.

Thelongitudinal struts114 have a curved shape operable to allow compression and expansion of thelongitudinal struts114 along thelongitudinal direction130 prior to rotation of the lateral struts112. For example, initial stretching ofsubstrate100 alongdirection130 may straighten thelongitudinal struts114 without rotation of the lateral struts112. But following the straightening or partial straightening of thelongitudinal struts114, further stretching ofsubstrate100 alongdirection130 may result in rotation oflateral struts112 andprojections116 as previously described herein.

Substrate100 is similar tosubstrates10,40 andsubstrates10,40 may be combined with elements and features with respect tosubstrate100 by including serpentine longitudinal struts with any of the features or elements described with respect tosubstrates10,40.

Embodiment 3

FIG.6 illustrates anexample substrate200 defininglongitudinal struts214 and rotatable lateral struts212 withmicroneedle projections216 extending from intermediate sections215 of the lateral struts212.Microneedle projections216 are operable to deliver a therapeutic fluid or collect a fluid sample, with at least some of the lateral struts212 andlongitudinal struts214 being of tubular construction and in fluid communication withmicroneedle projections216.

As shown,longitudinal struts214 includelumens224, andlateral struts212 includelumens222.Lumens222,224 are in fluid communication withcentral lumens226 ofmicroneedle projections216 and withfluid repository220 viamanifold221. In various embodiments,fluid repository220 may be used to deliver and or collect fluid viacentral lumens226 ofmicroneedle projections216. With the exception oflumens222,224 andcentral lumens226,substrate200 is otherwise similar tosubstrates10,40, and themicroneedle projections216 may be combined with elements and features previously described with respect tosubstrates10,40.

In some embodiments, thefluid repository220 is located adjacent a proximal end of a medical device including thesubstrate200. In other embodiments, thefluid repository220 is located adjacent a proximal end of a delivery device suitable to facilitate delivery of a medical device including thesubstrate200. Such a delivery device may be configured to induce the stretching of thesubstrate200. For example, the delivery device may include an elongated element to stretch the medical device in a longitudinal direction parallel to a major axis of the delivery device. In the same or different embodiments, delivery device may include a balloon to radially or longitudinally stretch thesubstrate200 in conjunction with or following the release of the medical device from a distal end of a tubular delivery element of the delivery device. In such balloon deployment embodiments,substrate200 may be a tubular substrate.

Substrate200 is similar tosubstrates10,40,100 andsubstrates10,40,100 may be combined with elements and features with respect tosubstrate200 by including microneedle projections and lumens with any of the features or elements described with respect tosubstrates10,40,100.

Embodiment 4

FIGS.7A and7B illustrate a balloon inflatable vasculardrug delivery system300. Vasculardrug delivery system300 includessubstrate310 with rotatable lateral struts312 withprojections316, andinflatable balloon350, and is suitable for intravascular delivery to a target site within a patient's vasculature. Upon reaching the target site vasculardrug delivery system300 facilitates deployment through remote inflation ofballoon350. Specifically,FIG.7A illustrates vasculardrug delivery system300 in a deflated configuration, whereasFIG.7B illustrates vasculardrug delivery system300 in an inflated configuration.

For example, vasculardrug delivery system300 may further include atherapeutic coating360 including a therapeutic agent covering all or portions ofsubstrate310, rotatable lateral struts312 withprojections316, and/orinflatable balloon350. As described previously, projections extending from rotatable struts, such asprojections316, may include a therapeutic compound, and/or represent microneedles configured to deliver a therapeutic fluid.

Vasculardrug delivery system300 is operable to apply a therapeutic agent, to the surrounding tissue along its length. For example, the therapeutic agent can be intimately applied to at least a majority portion of the surrounding tissue along this length.

In some embodiments, vasculardrug delivery system300 may be configured to displace at least a portion of a fluid, such as blood, along the length of a vessel and thus, substantially occlude the vessel along this length. In effect, the close proximity to the surrounding tissue and the displacement of blood can reduce the amount of therapeutic agent required for an effective treatment as well as the amount of therapeutic agent migrating away from the treatment site.

Substrate310 defines a tubularmajor surface309 including circumferential struts314 and rotatable lateral struts312 withprojections316 extending fromintermediate sections315 of the lateral struts312.Substrate310 is configured such that whensubstrate310 is stretched in a circumferential direction through the inflation ofballoon350, the lateral struts312 rotate relative to the circumferential struts314 and bend out of plane of themajor surface309 such that thebarbed projections316 rotate relative to the circumferential struts314.Major surface309 forms a tubular shape, the original plane of tubularmajor surface309 is also tubular. Geometrically, bending out of the plane of themajor surface309 may represent bending either inwardly and/or outwardly in a radial dimension.

The plane of a tubular major surface is a plane defined wherein a tubular substrate is longitudinally cut and laid open flat about a plane. In a tubular arrangement, the plane defined by a tangent to the tubular substrate major surface to describe the projections moving out of the local plane inwardly and/or outwardly in a radial dimension.

In the deflated configuration ofFIG.7A,projections316 are along themajor surface309 of the lateral struts312 and the circumferential struts314. In the inflated configuration ofFIG.7B, lateral struts312 withprojections316 are rotated to point outward from themajor surface309 ofcircumferential struts314 and from the original plane of tubularmajor surface309.

The tubularmajor surface309 ofsubstrate310, including circumferential struts314 and lateral struts312, defines a longitudinal axis330.Projections316 extend about perpendicular to longitudinal axis330 in both the stretched and unstretched configurations. As represented inFIG.7B,projections316 extend radially outward whensubstrate310 is radially stretched due to the rotation of theintermediate sections315 of the lateral struts312. Theprojections316 may remain coincident relative to thetubular substrate310 when thetubular substrate310 is radially unstretched, and theprojections316 may extend radially outward when radial stretching of the substrate induces rotation of lateral struts312 relative to the circumferential struts314.

In a modified embodiment, a tubular substrate may include rotatable circumferential struts which rotate in response to longitudinal stretching of the substrate. In such an embodiment, projections remain flat relative to the substrate when the substrate is longitudinally stretched and radially unstretched, and the projections may extend radially outward when longitudinal stretching of the substrate induces rotation of the circumferential struts relative to the lateral struts.

In various embodiments, thetubular substrate310 may be radially self-expandable. In such embodiment,tubular substrate310 may be constrained within an elongated tubular catheter prior to expansion, andballoon350 may be optional. Alternatively, following expansion oftubular substrate310 to an intermediate diameter,balloon350 may be used to further radially expandtubular substrate310 to an expanded diameter, for example, to drivebarbed projections316 into a patient tissue or other material.

For example,tubular substrate310 may be radially self-expandable from a collapsed diameter within an elongated tubular catheter to an intermediate diameter and radially balloon-expandable to an expanded diameter from the intermediate diameter. In some of such embodiments, theintermediate sections315 of the lateral struts312 rotate relative to the circumferential struts314 between the collapsed diameter and the expanded diameter. In some of such embodiments, theintermediate sections315 of the lateral struts312 may not significantly rotate relative to the circumferential struts314 between the collapsed diameter and the intermediate diameter during the self-expansion, but instead mostly rotate between the intermediate diameter and the expanded diameter during the balloon-expansion.

Substrate310 is similar tosubstrates10,40,100,200 andsubstrates10,40,100,200 may be combined with elements and features with respect tosystem300 by modifying or replacingsubstrate310 with any of the features or elements described with respect tosubstrates10,40,100,200.

In embodiments in whichprojections316 represent microspikes (with or without central apertures), covered with a therapeutic material, and stretching ofsubstrate310 fractures the therapeutic coating to facilitate delivery of the therapeutic coating to a patient tissue adjacent the therapeutic coating. The microspikes may be used to create drug depot locations in a vessel wall, such as an artery wall. Such techniques may not only provide relatively high percentage drug tissue concentrations, but locations where the depots gets lodged (to prevent simply having the drug particles being washed downstream after balloon treatment). In such embodiments,microspike projections316 become exposed during balloon inflation to help disrupt the internal elastic lamina layer of a vasculature. Themicrospike projections316 are retracted prior to inflation and may also be protected during delivery to the target site. In some embodiments, thetherapeutic material360 may contain a combination of solubilized formulation of a therapeutic compound along with slow-dissolving paclitaxel crystals.

In some embodiments,balloon350 may be covered with thetherapeutic material360 andmicrospike projections316 may function to radially align crystals to be directed into the internal elastic lamina layer of a vasculature, rather than simply press up against the internal elastic lamina layer of a vasculature during inflation of a similar system withoutsubstrate310.Microspike projections316 in the deployed state (FIG.7B) break-uptherapeutic material360 and can create a higher proportion of vertically oriented drug formulation particles and resulting drug retention into the artery wall after inflation and deflation. In contrast a similar system withoutsubstrate310 may simply push flat formulation pieces (most in-plane to the balloon surface and to the vessel luminal wall) towards the wall with little mechanism for formulation adhesion to the wall after the balloon is deflated and vessel blood flow is restored. Thus, the inclusion ofsubstrate310 with microspike projections within a drug delivery system may result in improved drug delivery efficiency, and a reduction in drug amount delivered to patient blood.

Generally it may be preferable formicrospike projections316 to retract upon balloon deflation, such that the material ofsubstrate310 should be of sufficient elasticity to collapse upon balloon deflation. Such materials may include nitinol, or other metals.

In some embodiments,microspike projections316 may extend between 200 and 1000 micrometers, such as about 500 micrometers. Such lengths may allow drug formulation to penetrate from the endothelium thru the media toward the adventitia, which is the targeted area and site of greatest drug retention. This may allow drug delivery thru the fibrous cap on arterial wall plaque segments.

In the same or different embodiments, vasculardrug delivery system300 may include from about 25 to about 50microspike projections316 for a balloon size of 5 millimeters diameter by about 40 millimeters long. These dimensions and number ofmicrospike projections316 are merely examples, and other dimensions and number of projections may be selected for various applications.

In the same or different embodiments,microspike projections316 may deploy upon balloon inflation to about half of the final diameter. Such a configuration may radially align fragments for delivery to variety of vessel diameters ranging from about half of the final diameter to the final diameter.

Balloon350 may be selected according to the design requirements of the particular application, including the resistance to deployment provided bysubstrate310 andtherapeutic material360, as well as a desired range of radial force to be applied to a vessel wall during deployment to improve delivery of thetherapeutic material360 without causing undesirable damage to the vessel wall.

For example, balloon formation can be carried out in any conventional manner using known extrusion, blow molding and other molding techniques. Typically, three major steps in the process include extruding a tubular preform, molding the balloon and annealing the balloon. Depending on the balloon material employed, the preform can be axially stretched before it is blown.

The balloon can be attached to an elongate member (not shown) to facilitate delivery within a vasculature by various bonding techniques known to the skilled artisan. Embodiments include, but are not limited to, solvent bonding, thermal adhesive bonding and heat shrinking or sealing. The selection of the bonding technique is dependent upon the materials from which the expandable element and tubular body are prepared.

According to the present disclosure, the balloon can be formed using any materials known to those of skill in the art with the desired physical properties. Commonly employed materials include the thermoplastic elastomeric and non-elastomeric polymers and the thermosets.

In anexample system300, the collapsed diameter of 6 French allowed for a 5 millimeter deployed diameter with a 40 millimeter balloon length, representing a 250 percent balloon expansion. This example may be adjusted to correspond to other vessel sizes, including, but not limited to, 4-8 millimeter diameters, 40-200 millimeter lengths, 6 French introducer sheath size, or 7 French introducer sheath size for delivery of balloons with 7 or 8 millimeter deployed diameters.

In below the knee applications: 2.0-4.0 millimeter diameters, 40-200 millimeter lengths, and 4-5 French introducer profile may be utilized.

In any of these examples, the formulation oftherapeutic material360 may be somewhat brittle to facilitate break up and release frommicrospike projections316 andballoon350 when deployed.

System300 facilitates a variety of coating options. As one example,therapeutic material360 may be overballoon350, but undersubstrate310. Such an embodiment allowsmicrospike projections316 to deploy without interference fromtherapeutic material360. Also, with this embodiment,substrate310 protectstherapeutic material360 during tracking and primary lesion. In variations of this embodiment,balloon350 may be dip coated before loadingsubstrate310 onballoon350.

In another example,therapeutic material360 may be overballoon350, andsubstrate310, as shown inFIG.7A. In such an example, deployment allowsmicrospike projections316 to force the breakup oftherapeutic material360. In variations of this embodiment, all ofsubstrate310 and balloon may be dip coated after loadingsubstrate310 onballoon350.

In another example,therapeutic material360 may be only coated on all or a portion ofsubstrate310, such as coated onmicrospike projections316. Such an example would allowtherapeutic material360 to penetrate the vessel wall. This example, may result in the highest proportion oftherapeutic material360 being delivered to the vessel wall. In variations of this embodiment, all ofsubstrate310 may be dip coated before loading onballoon350.

Embodiments in whichballoon350 is covered withtherapeutic material360 and the microneedles ofprojections316 function to radially align crystals to be directed into the internal elastic lamina layer of a vasculature, may provide one or more advantages as compared to a similar drug delivery system withoutsubstrate310. For example, the applied techniques may provide enhanced patient safety due to: a reduction in paclitaxel drug content/device, a reduced procedure time due to no requirement for a pre-dilatation balloon inflation prior to deployment (primary angioplasty ability), a reduced inflation time, a reduction in particles delivered distally via blood stream, and a reduced occurrence of segment drug overdosing, a reduction in vessel dissections and reduction in vessel recoil needing stenting due to forced concentric dilatation of vessel during angioplasty, enhanced clinical outcomes as a result of increased improvement in drug uptake consistency, and improvement in drug delivery efficiency, a reduced occurrence of segment drug underdosing, and/or forced concentric inflation fromsubstrate310, resulting in reduced vessel dissections and vessel recoil.Microspike projections316 may also protect a drug formulation during introducer valve crossing and tracking to treatment site, which may mitigate loss of formulation in tortuous arteries prior to inflation and may enable primary angioplasty. Such advantages may provide outcomes result in a greater treatment success, more consistent patient success and across a larger patient group (i.e., reduced number of clinical “non-responders”) compared to similar drug delivery system withoutsubstrate310.

Embodiment 5

FIGS.8A-8C illustrate deployment of barbed sleeves from projections to secure two tissue layers together. Specifically,FIG.8A illustratesvessel460 withtissue layers462,464 separated from one another. As an example,FIG.8A may represent a vessel dissection, with thetissue layer462 being a vessel wall and thetissue layer464 being an intimal flap.

FIG.8B illustrates a balloon inflatablevascular delivery system400. Thevascular delivery system400 includessubstrate410 with rotatable lateral struts412 withprojections416, circumferential struts (not shown inFIG.8B) andinflatable balloon450, and is suitable for intravascular delivery to a target site within a patient's vasculature viaelongated member440. Thevascular delivery system400 may further include a delivery device (not shown). Upon reaching the target site, the vasculardrug delivery system400 facilitates deployment through remote inflation of theballoon450.

Thevascular delivery system400 and its variations are the same or similar to those described with respect to thevascular delivery system300, with the exception of the addition ofcaps420 over the distal ends of theprojections416. In some embodiments, thecaps420 may represent coating or releasable sheaths on theprojections416.

Since theprojections416 lay flat against theballoon450 in the un-deployed state, thecaps420 are deployable within a patient's vasculature withvascular delivery system400. Upon arrival at the target therapy site, theballoon450 may be remotely inflated and theprojections416 will rotate into place during deployment, as described previously, e.g., with respect todelivery system300. Inflation of theballoon450 may the cause theprojections416 and thecaps420 to embed into the vessel wall, including the tissue layers462,464, as shown inFIG.8B. In the specific embodiment shown, caps420 may represent a barbed sleeve, suitable for tacking tissue layers462,464 together, for example, to repair an intimal flap. As shown in the enlarged portion ofFIG.4B, acap420 includes apointed tip422 andbarbs426 on the walls ofcap420. In the same or different embodiment, caps420 may include drugs that can be driven into a vessel wall and left behind following the removal or retraction of theprojections416.

As shown inFIG.8C,vascular delivery system400 has been withdrawn from the vessel, leavingcaps420 behind. In this specific embodiment, the intimal flap has been repaired ascaps420 function to securetissue layer464 totissue layer462.

Thecaps420 may also be used to deliver a therapeutic agent to the vessel wall. Thecaps420 may be permanent or bio-absorbable. Thecaps420 may be textured or barbed as to lock into the tissue. For example, thecaps420 themselves may comprise barbs which assist in anchoring the sheath in place. Thecaps420 may be polymeric or metallic. Thecaps420 may comprise swellable portions. For instance, tips ofcaps420 may be coated in a hydrogel which swells as it absorbs moisture. This swelling tip may help to anchor thecaps420 in place.

Substrate410 is similar tosubstrates10,40,100,200,310 andsubstrates10,40,100,200,310 may be combined with elements and features with respect tosystem400 by modifying or replacingsubstrate410 with any of the features or elements described with respect tosubstrates10,40,100,200,310.

Embodiment 6

FIGS.9A-9D illustrate amedical device500 suitable for endoluminal delivery.Medical device500 includes a diametrically adjustabletubular substrate510 with substrate560 defining rotatable lateral struts512 with raisededges515 andcircumferential struts514 mounted onelongated member540. Raisededges515 are suitable for removing thrombus from a vasculature, as described with respect toFIGS.10A-10C.

Substrate510 defines a tubularmajor surface509 including circumferential struts514 and rotatable lateral struts512.Substrate510 is configured such that whensubstrate510 is stretched in a circumferential direction through the inflation ofballoon550, the lateral struts512 rotate relative to the circumferential struts514 and bend out of plane of themajor surface509 such that the raisededges515 extend radially outward.

Medical device500 may be part of a vascular delivery system suitable for intravascular delivery to a target site within a patient's vasculature viaelongated member540. The vascular delivery system may further include an inflatable balloon and/or a delivery device (not shown). Such a vascular delivery system and its variations are the same or similar to those described with respect to thevascular delivery system300, with the exception of the absence of projections from the lateral struts512. For example, upon arrival at a target therapy site, the balloon may be remotely inflated and the lateral struts512 will rotate into place during deployment, as described previously, e.g., with respect todelivery system300.

Substrate510 is similar tosubstrates10,40,100,200,310,410 andsubstrates10,40,100,200,310,410 may be combined with elements and features with respect tomedical device500 by modifying or replacingsubstrate510 with any of the features or elements described with respect tosubstrates10,40,100,200,310,410.

FIGS.10A-10C illustrate removing athrombus565 from avasculature562 of a patient using themedical device500. Thethrombus565 is a vessel occlusion, which may substantially prevent blood flow through thevasculature562. Themedical device500 may be used to scrape and clear thethrombus565 as shown. First, themedical device500 is delivered to the target therapy site, i.e., the location ofthrombus565 in the vasculature562 (FIG.10A). Then, the distal end of themedical device500, including thesubstrate510 is pushed into the thrombus565 (FIG.10B). Next, thesubstrate510 is expanded, for example, with a balloon (not shown) to rotate the lateral struts512 and expose the raised edges515. The exposed raisededges515 are then used to scrape and clear thethrombus565 by rotating thesubstrate510 and or moving the substrate longitudinally within thevasculature562, for example, via remote operation of elongated member540 (FIG.10C). The raised edges515 of the lateral struts512 may act as a scoop to remove thethrombus565 from the walls of thevasculature562. A bag or other filter (not shown) may be used to capture released dislodged thrombotic particles downstream within thevasculature562. The same or similar techniques may be used to remove plaque from within thevasculature562.

Embodiment 7

In some embodiments, and referring toFIG.7B, thetubular substrate310 could be suitable for intravascular delivery to a target site within a patient's vasculature.

Thetubular substrate310 could be deployed by balloon (not shown), until theprojections316 reach and pierce the vessel. In this embodiment,projections316 would be configured with texture or barbs to enable them to engage and grip tissue, such as those illustrated inFIG.4B,FIG.4C,FIG.4D andFIG.4G. Upon balloon deflation,projections316 with barbs will pull the vessel or host tissue down with it. In this instance, thetubular substrate310 may be left in the vessel and act to reduce the vessel diameter.

Such techniques may be applied to standardize the ostium of the left atrial appendage, to restore competency to a venous valve, to build a landing zone for an abdominal aneurysm stent-graft just below the renal arteries, and/or to completely close a vessel (fully occlude). In some of such embodiments, thetubular substrate310 may operate as “reverse” stent. In some of such embodiments,tubular substrate310 may be formed from a shape memory alloy heat set in a collapsed diameter. In such embodiments,projections316 may be heat set outward or heat set to rotate outward with rotatable lateral struts312 during the expansion oftubular substrate310 from a collapsed diameter to an expanded diameter.

In some of such embodiments, theprojections316 may be constrained by the delivery catheter device prior to deployment of thetubular substrate310 from the distal end of the delivery catheter device.

In the same or different embodiments, thetubular substrate310 may be mounted on a balloon to facilitate radial expansion of thetubular substrate310 and/or penetration of theprojections316 within a patient tissue or graft material. Inflating the balloon will drive the barbs into the tissue or graft material. Deflating the balloon will allow thetubular substrate310 to draw the orifice closed.

At the entrance of the left atrial appendage, the sheath would be pulled back, deploying theprojections316, which serve as anchors. Inflating the balloon will drive the barbs into the tissue. Deflating the balloon will allow the stent to draw the orifice closedtubular substrate310 to draw the orifice closed. In this manner, the stent is configured to radially collapse to draw together tissue surfaces captured by the plurality of projections.

While this technique is described with respect to cause occlusion of the ostium of a left atrial appendage of a patient, it may be radially applied to draw together other tissues. For example,tubular substrate310 may be deployed to cause occlusion of a blood vessel, to cause occlusion of a tubular conduit or organ, to facilitate closure of a wall defect, to facilitate closure of a topical wound, to facilitate closure of an internal wound, or to facilitate occlusion of closure of an orifice or void within a patient.

In the same or different embodiments, a medical device including thetubular substrate310 may further include a collar configured to substantially cover a central lumen of thetubular substrate310. Optionally, such a collar could then be slid ontotubular substrate310, closing the orifice completely. The tabs opposite theprojections316 could be used to trap the collar. If desired for further fixation, a Septal defect closure device (such as Gore Helex or Eclipse) could be deployed through the central lumen oftubular substrate310.

Tubular substrate310 may be combined with other techniques for occluding a left atrial appendage of a patient, for example, as described in U.S. Pat. No. 9,186,152, titled LEFT ATRIAL APPENDAGE OCCLUSIVE DEVICES, which is incorporated by reference herein for all purposes.

Embodiment 8

A medical system may include a medical device with a tubular substrate corresponding to one of thesubstrates10,40,100,200,310,410, or510, and a delivery device configured to deliver the medical device within a vasculature of a patient with the medical device in a collapsed configuration. The delivery device is operable to deploy the tubular substrate within the vasculature. Deployment of the medical device includes stretching of the tubular substrate to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts. The tubular substrate is configured to engage an inner wall of the vasculature.

In some of such embodiments, the deployment of the medical device includes stretching of the tubular substrate to the expanded configuration such that the lateral struts and the projections are configured to rotate relative to the longitudinal struts. The projections may be configured to penetrate an inner wall of the vasculature.

In the same or different embodiments, the tubular substrate forms at least a portion of a stent. For example, the projections may function as tissue engagement members of stent or stent graft as described in U.S. Pat. No. 9,333,101, titled MEDICAL DEVICE FIXATION ANCHORS, which is incorporated by reference herein for all purposes.

In some of such embodiments in which the tubular substrate forms at least a portion of a stent, the medical device may further comprise a tubular graft layered with the substrate to form a stent graft.

Embodiment 9 (Valve Embodiment)

A medical system may include a medical device with a tubular substrate corresponding to one of thesubstrates10,40,100,200,310,410, or510, and a delivery device configured to deliver the medical device within a vasculature of a patient with the medical device in a collapsed configuration. The delivery device is operable to deploy the tubular substrate within the vasculature. Deployment of the medical device includes stretching of the tubular substrate to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts.

The substrate of the medical device includes projections operable to penetrate at least one of tissue of a patient and graft material of an implantable medical device, such a graft material of a heart valve device as part of a valve-in-a-valve implantation procedure.

Embodiment 10

A medical system may include a medical device with a substrate corresponding to one of thesubstrates10,40,100,200,310,410, or510, and a delivery device configured to deliver the medical device within a confined orifice of a patient. The substrate is a flat sheet curled up within the delivery device. The delivery device is operable to deploy the substrate within the confined orifice such that the flat sheet at least partially uncurls within the confined orifice.

Deployment of the medical device may include stretching of the substrate to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts.

In some of such embodiments, the medical device is configured to be used as a hernia patch with the projections being configured to contact or penetrate a patient tissue following deployment of the substrate from the delivery device. In such embodiments, projections may be configured to contact or penetrate a tissue of the patient adjacent an opening in the tissue at a herniation. For example, the substrate may function as a hernia patch as described in United States Patent Application Publication No. 2012/0065649, titled SURGICAL MESH, which is incorporated by reference herein for all purposes.

Some representative embodiments of this disclosure may be characterized according to the following clauses.

Clause 1: A medical device comprising: a substrate defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction that are interconnected with a plurality of second struts extending along a second direction not parallel with the first direction along the major surface, wherein widths of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend out of the plane of the major surface.

Clause 2: The medical device of clause 1, wherein the first direction is perpendicular to the second direction.

Clause 3: The medical device of clause 1 or clause 2, wherein the plurality of second struts alternately extend at an angle to a transverse direction defining a serpentine portion with peaks and valleys with the plurality of first struts interconnecting the plurality of second struts adjacent apexes of the peaks and valleys.

Clause 4: The medical device of clause 3, wherein the serpentine portion include V-shaped portions including the peaks and valleys.

Clause 5: The medical device of clause 3, wherein the serpentine portion include U-shaped portions including the peaks and valleys.

Clause 6. The medical device of any of clauses 1-5, wherein the plurality of first struts have a curved shape operable to allow expansion of the first struts along the first direction prior to the rotation of the intermediate sections of the second struts as the substrate is stretched along the direction perpendicular to the first direction.

Clause 7: The medical device of any of clauses 1-6, wherein the substrate comprises one or more of: metal, plastic, superelastic metals, and shape memory materials.

Clause 8: The medical device of any of clauses 1-7, wherein the substrate includes nitinol operable to self-expand to elongate the substrate along the direction perpendicular to the first direction or self-contract to retract the substrate along the direction perpendicular to the first direction.

Clause 9: The medical device of any of clauses 1-8, wherein the stretching of the substrate along the direction perpendicular to the first direction results in plastic deformation of the substrate.

Clause 10: The medical device of any of clauses 1-8, wherein the stretching of the substrate along the direction perpendicular to the first direction results in elastic deformation of the substrate.

Clause 11: The medical device of any of clauses 1-10, wherein the substrate is flat.

Clause 12: The medical device of any of clauses 1-10, wherein the substrate is a tubular substrate.

Clause 13: The medical device ofclause 12, wherein the tubular substrate is radially self-expandable.

Clause 14: The medical device ofclause 12 orclause 13, wherein the tubular substrate is radially balloon-expandable.

Clause 15: The medical device ofclause 14, wherein the tubular substrate is radially self-expandable to an intermediate diameter from a collapsed diameter, wherein the tubular substrate is radially balloon-expandable to an expanded diameter from the intermediate diameter, and wherein the intermediate sections of the second struts rotate relative to the first struts between the collapsed diameter and the expanded diameter.

Clause 16: The medical device ofclause 15, wherein the intermediate sections of the second struts rotate relative to the first struts between the intermediate diameter and the expanded diameter, and wherein the intermediate sections of the second struts do not significantly rotate relative to the first struts between the collapsed diameter and the intermediate diameter.

Clause 17: The medical device of any of clauses 1-16, further comprising a therapeutic coating covering at least a portion of the substrate, wherein the rotation of the intermediate sections from the stretching of the substrate along the direction perpendicular to the first direction fractures the therapeutic coating to facilitate delivery of the therapeutic coating to a patient tissue adjacent the therapeutic coating.

Clause 18: The medical device of any of clauses 1-17, further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts, wherein, when the substrate is stretched along the direction perpendicular to the first direction, the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative to the plurality of first struts.

Clause 19: The medical device of clause 18, further comprising caps over distal ends of each of the plurality of projections, the caps being configured to remain within a patient tissue following insertion and removal of the distal ends into the patient tissue.

Clause 20: The medical device of clause 18, wherein the plurality of projections each extend within the substrate parallel to the first struts.

Clause 21: The medical device of any of clauses 18-20, wherein the plurality of projections extend from opposing sides of the plurality of second struts such that when the substrate is stretched along the direction perpendicular to the first direction, the plurality of projections rotate with the intermediate sections of the plurality of second struts to project in opposing directions relative to the plurality of first struts.

Clause 22: The medical device of any of clauses 18-21, wherein the plurality of projections define anchors, each anchor including a pointed tip.

Clause 23: The medical device ofclause 22, wherein the anchors are operable to penetrate at least one of tissue of a patient and graft material of an implantable medical device.

Clause 24: The medical device ofclause 22 or clause 23, wherein the anchors each include a base portion, a tip end portion distal to the base portion, and a body portion between the base portion and the tip end portion, wherein the base portion is integral with one of the intermediate sections of the plurality of second struts.

Clause 25: The medical device of clause 24, wherein the anchors are operable to penetrate tissue of a vessel and wherein the tip end portion is operable to prevent pullout once penetrated into tissue.

Clause 26: The medical device of clause 24 or clause 25, wherein a form of the tip end portion is selected from a group consisting of: pointed, arrowhead, single sided arrowhead, barbed, textured, rectangular, square, oval, circular, diamond, triangular, elliptical, polygonal, U-shaped, and star-shaped.

Clause 27: The medical device of any of clauses 22-26, wherein the anchors are operable to perform one of more of: anchor into tissue, deliver drugs to tissue, stimulate tissue, conceal tissue, expose tissue, secure tissues together, and secure tissue to a medical device.

Clause 28: The medical device of any of clauses 22-27, wherein the anchors each include a removable distal section.

Clause 29: The medical device of clause 28, wherein the removable distal section includes one or more of: a barbed sleeve, an erodible portion, an absorbable portion, a break-off distal portion, a tacky distal portion, a barbed, break-off distal tip, a therapeutic compound, and biological moieties.

Clause 30: The medical device of any of clauses 18-21, wherein the plurality of projections are microneedles including lumens in fluid communication with a manifold and a fluid repository, and wherein the microneedle are operable to deliver a therapeutic fluid or collect a sample via the lumens and the manifold.

Clause 31: The medical device ofclause 30, wherein at least some of the first and second struts are of tubular construction and having lumens and in fluid communication with the microneedles and the fluid repository.

Clause 32: The medical device ofclause 30 or clause 31, wherein the fluid repository is located adjacent a proximal end of a delivery device suitable to facilitate delivery of the medical device.

Clause 33: The medical device ofclause 30 or clause 31, wherein the fluid repository is located adjacent a proximal end of the medical device.

Clause 34: The medical device of any of clauses 18-33, further comprising a therapeutic coating covering the plurality of projections, wherein the rotation of the plurality of projections from the stretching of the substrate along the direction perpendicular to the first direction fractures the therapeutic coating to facilitate delivery of the therapeutic coating to a patient tissue adjacent the therapeutic coating.

Clause 35: The medical device of any of clauses 18-34, wherein the substrate is a tubular substrate, wherein the tubular substrate defines a lumen having a longitudinal axis, wherein the plurality of projections remain coincident relative to the substrate when the substrate is radially unstretched, and wherein the plurality of projections extend radially outward when radial stretching of the substrate induces rotation of the second struts relative to the first struts.

Clause 36: The medical device of clause 35, wherein the plurality of projections remain flat relative to the substrate when the substrate is longitudinally stretched and radially unstretched.

Clause 37: The medical device of any of clauses 18-34, wherein the substrate is a tubular substrate, wherein the tubular substrate defines a lumen having a longitudinal axis, wherein the plurality of projections remain coincident relative to the substrate when the substrate is longitudinally unstretched, and wherein the plurality of projections extend radially outward when longitudinal stretching of the substrate induces rotation of the second struts relative to the first struts.

Clause 38: The medical device of clause 37, wherein the plurality of projections remain flat relative to the substrate when the substrate is radially stretched and longitudinally unstretched.

Clause 39: The medical device of any of clauses 35-38, wherein the medical device is configured to radially collapse to draw together tissue surfaces captured by the plurality of projections.

Clause 40: The medical device ofclause 39, wherein the medical device further includes a collar configured to substantially cover the lumen.

Clause 41: The medical device of any of clauses 35-40, wherein the tubular substrate is radially self-expandable.

Clause 42: The medical device ofclause 41, wherein the tubular substrate is radially balloon-expandable.

Clause 43: The medical device ofclause 42, wherein the tubular substrate is radially self-expandable to an intermediate diameter from a collapsed diameter, wherein the tubular substrate is radially balloon-expandable to an expanded diameter from the intermediate diameter, and wherein the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative to the plurality of first struts between the collapsed diameter and the expanded diameter.

Clause 44: The medical device ofclause 43, wherein the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative to the plurality of first struts between the intermediate diameter and the expanded diameter, and wherein the plurality of projections remain flat relative to the substrate when the substrate expands from the collapsed diameter to the intermediate diameter.

Clause 45: The medical device of any of clauses 12-17 and 35-44, wherein the tubular substrate forms at least a portion of a stent.

Clause 46: The medical device ofclause 45, further comprising a tubular graft layered with the substrate to form a stent graft.

Clause 47: A medical system comprising: the medical device of any of clauses 1-46, and a delivery device configured to induce the stretching of the substrate, wherein a deployment of the medical device includes stretching of the substrate such that the second struts rotate relative to the first struts.

Clause 48: A medical system comprising: the medical device of any of clauses 18-34, and a delivery device configured to deliver the medical device within a confined orifice of a patient, wherein the substrate is a flat sheet curled up within the delivery device, wherein the delivery device is operable to deploy the substrate within the confined orifice such that the flat sheet at least partially uncurls within the confined orifice, and wherein the medical device is configured to be used as a hernia patch with the plurality of projections being configured to contact or penetrate a tissue of the patient adjacent an opening in the tissue at a herniation.

Clause 49: A medical system comprising: the medical device of any of clauses 12-17 and 35-46, and a delivery device configured to deliver the medical device within a vasculature of a patient with the medical device in a collapsed configuration, wherein the delivery device is operable to deploy the tubular substrate within the vasculature, and wherein a deployment of the medical device includes stretching of the tubular substrate to an expanded configuration such that the second struts rotate relative to the first struts.

Clause 50: The medical system ofclause 49, wherein, when the tubular substrate is deployed in the expanded configuration, raised edges of the tubular substrate are configured to scrape and clear thrombus from within the vasculature.

Clause 51: The medical system ofclause 49, wherein, when the tubular substrate is deployed in the expanded configuration, the tubular substrate is configured to engage an inner wall of the vasculature.

Clause 52: A medical system ofclause 49, wherein the medical device is the medical device of any of clauses 35-46, and wherein a deployment of the medical device includes stretching of the tubular substrate to the expanded configuration such that the second struts and the plurality of projections rotate relative to the first struts.

Clause 53: The medical system of clause 52, wherein the plurality of projections are configured to penetrate an inner wall of the vasculature.

Clause 54: A method of manufacturing the medical device of any of clauses 1-46, the method comprising: cutting a sheet of substrate material to form the substrate including the plurality of first struts and the plurality of second struts, wherein the plurality of first struts are interconnected with the plurality of second struts in the cut sheet of substrate material.

Clause 55: The method of clause 54, wherein the medical device is the medical device of any of clauses 18-46, and wherein cutting the sheet of substrate material to form the substrate further includes forming the plurality of projections extending from the intermediate sections of the second struts.

Clause 56: The method of clause 54 of clause 55, further comprising stretching the substrate along the direction perpendicular to the first direction to rotate the second struts relative to the first struts and bend the intermediate sections of the second struts in the plane parallel to the widths of the second struts as the substrate elongates along the direction perpendicular to the first direction.

The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims (16)

What is further claimed is:

1. A medical device comprising:

a substrate defining a major surface, the major surface including a plurality of first struts extending along a first longitudinal direction that are interconnected with a plurality of second struts extending along a second direction not parallel with the first longitudinal direction along the major surface,

wherein widths of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first longitudinal direction, intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend away from the major surface.

2. The medical device ofclaim 1, wherein the first longitudinal direction is perpendicular to the second direction.

3. The medical device ofclaim 1, wherein the plurality of second struts alternately extend at an angle to a transverse direction defining a serpentine portion with peaks and valleys with the peaks or valleys of the plurality of first struts interconnecting the peaks or valleys of the plurality of second struts at adjacent apexes.

4. The medical device ofclaim 1, wherein the plurality of first struts have a curved shape operable to allow expansion of the first struts along the first longitudinal direction prior to rotation of the intermediate sections of the second struts as the substrate is stretched along the direction perpendicular to the first longitudinal direction.

5. The medical device ofclaim 1, wherein the substrate is a tubular substrate.

6. The medical device ofclaim 5,

wherein the tubular substrate is radially self-expandable to an intermediate diameter from a collapsed diameter,

wherein the tubular substrate is radially balloon-expandable to an expanded diameter from the intermediate diameter, and

wherein the intermediate sections of the second struts rotate relative to the first struts between the collapsed diameter and the expanded diameter.

7. The medical device ofclaim 5, further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts,

wherein the medical device is configured to radially collapse to draw together tissue surfaces captured by the plurality of projections.

8. The medical device ofclaim 5, wherein the tubular substrate forms at least a portion of a stent, the medical device further comprising a tubular graft layered with the substrate to form a stent graft.

9. The medical device ofclaim 1, further comprising a therapeutic coating covering at least a portion of the substrate, wherein rotation of the intermediate sections from the stretching of the substrate along a direction perpendicular to the first longitudinal direction fractures the therapeutic coating to facilitate delivery of the therapeutic coating to a patient tissue adjacent the therapeutic coating.

10. The medical device ofclaim 1,

further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts,

wherein, when the substrate is stretched along a direction perpendicular to the first longitudinal direction, the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative to the plurality of first struts.

11. A medical system comprising:

a medical device including a substrate defining a major surface, the major surface including a plurality of first struts extending along a first longitudinal direction that are interconnected with a plurality of second struts extending along a second direction not parallel with the first longitudinal direction along the major surface, wherein widths of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first longitudinal direction, intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend away from the major surface; and

a delivery device configured to induce the stretching of the substrate,

wherein a deployment of the medical device includes stretching of the substrate such that the second struts rotate relative to the first struts.

12. The medical system ofclaim 11, further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts, wherein the delivery device is configured to deliver the medical device within a confined orifice of a patient,

wherein the substrate is a flat sheet curled up within the delivery device,

wherein the delivery device is operable to deploy the substrate within the confined orifice such that the flat sheet at least partially uncurls within the confined orifice, and

wherein the medical device is configured to be used as a hernia patch with the plurality of projections being configured to contact or penetrate a tissue of the patient adjacent an opening in the tissue at a herniation.

13. The medical system ofclaim 11,

wherein the substrate of the medical device is a tubular substrate,

wherein the delivery device is configured to deliver the medical device within a vasculature of a patient with the medical device in a collapsed configuration,

wherein the delivery device is operable to deploy the tubular substrate within the vasculature, and

wherein a deployment of the medical device includes stretching of the tubular substrate to an expanded configuration such that the second struts rotate relative to the first struts.

14. The medical system ofclaim 13, wherein, when the tubular substrate is deployed in the expanded configuration, raised edges of the tubular substrate are configured to scrape and clear thrombus from within the vasculature.

15. The medical system ofclaim 13, wherein, when the tubular substrate is deployed in the expanded configuration, the tubular substrate is configured to engage an inner wall of the vasculature.

16. A medical device comprising:

a substrate defining a major surface, the major surface including a plurality of first struts extending along a first longitudinal direction that are interconnected with a plurality of second struts extending along a second direction along the major surface; and

a therapeutic coating covering at least a portion of the substrate,

wherein intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend away from the major surface, and

wherein rotation of the intermediate sections from the stretching of the substrate along the first longitudinal direction fractures the therapeutic coating to facilitate delivery of the therapeutic coating to a patient tissue adjacent the therapeutic coating.

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